Must Have Technical/Functional Skills
• 5+ years of hands-on testing experience in medical device or regulated industry
• Strong experience in: Executing IQ/OQ/PQ protocols, Protocol reading and step-by-step execution, Test data recording and documentation
• Familiarity with: Lab instruments (multimeters, oscilloscopes, sensors, etc.), Equipment validation processes
• Understanding of GxP and validation practices
• Experience with Veritas Console or similar medical equipment
• Exposure to equipment validation in manufacturing or R&D labs
Roles & Responsibilities
We are looking for a hands-on V&V Test Engineer responsible for executing validation protocols on medical device equipment (Veritas Console). The role primarily involves protocol-based testing, data recording, and documentation to ensure equipment meets defined performance and regulatory requirements.
Key Responsibilities
Protocol Execution
• Execute pre-approved validation protocols (IQ/OQ/PQ) for medical equipment such as Veritas Console.
• Follow detailed step-by-step test procedures and ensure strict adherence to instructions.
• Set up test environments, instruments, and equipment as per protocol requirements.
Testing Activities
• Perform functional, operational, and performance testing of equipment.
• Conduct tests under various conditions and scenarios defined in protocols.
• Capture accurate test results, observations, and evidence during execution.
Documentation & Reporting
• Record test results in protocol documents, logbooks, and validation reports.
• Document any deviations, anomalies, or failures observed during testing.
• Ensure completeness and compliance of executed protocols per quality standards.
Defect & Issue Handling
• Identify and report defects or non-conformances.
• Work closely with engineering and quality teams for issue resolution.
• Retest equipment after fixes as required.
Compliance & Quality
• Ensure all activities comply with:
o GxP guidelines
o FDA 21 CFR Part 820 / 11
o ISO 13485
• Maintain proper traceability and document control.
Equipment Handling
• Operate and handle medical equipment, test setups, and measurement instruments safely.
• Ensure calibration status of instruments before testing.
Salary Range: $80,000- $90,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
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